Coronary

Clinical Impact of Stent Design

R ebec c a L N o a d , 1 Co l m G H a n ra t t y 2 a n d S i m o n J Wa l s h 2

1. Specialist Registrar in Cardiology; 2. Consultant Cardiologist, Belfast City Hospital, Belfast Health and Social Care Trust,
Belfast, Northern Ireland, UK

Abstract
The introduction and widespread adoption of drug-eluting stents into routine clinical practice has seen tremendous changes in the
practice of interventional cardiology. For a prolonged period, manufacturers have focused research on drugs and polymers that are
the key to the prevention of in-stent restenosis. However, stent platform design and its clinical implications have now come back to the
fore. This has occurred for numerous reasons, but has primarily been driven by the need for modern stents to perform well in increasingly
demanding clinical scenarios. This paper reviews the historical evolution of stent platform design. Current manufacturing processes and
materials are also explored. Geometric stent construction and its implications for longitudinal stability and the longer term risks of stent
fracture are reviewed. Finally, the implications of the specific stent chosen for different clinical applications including the treatment of
bifurcations and left main disease are also summarised. This article will familiarise cardiologists with the crucial impact of each of these
factors on modern day practice, as well as acute and long-term outcomes for patients.

Keywords
Stent design, longitudinal compression, stent fracture, stent thrombosis, left main stem stenting

Disclosure: Colm G Hanratty is a consultant to Boston Scientific. Simon J Walsh is a consultant to Abbott Vascular, Biosensors and Boston Scientific. Rebecca L Noad has
no conflicts of interest to declare.
Received: 2 April 2014 Accepted: 28 April 2014 Citation: Interventional Cardiology Review, 2014;9(2):89–93
Correspondence: Simon J Walsh, Consultant Cardiologist, Belfast City Hospital, 51 Lisburn Road, Belfast, BT9 7AB, Northern Ireland, UK.
E: simon.walsh@belfasttrust.hscni.net

As the role of percutaneous coronary intervention (PCI) has evolved,
inevitably, so too has the technology associated with this specialty.
Initially, plain old balloon angioplasty (POBA) was developed as a
strategy to ‘stretch’ focal stenoses within the coronary arteries
leading to a relief from ischaemia and angina. Whilst potentially of
great benefit to some patients, POBA was beset by a series of Achilles’
heels. These included early, unpredictable and abrupt vessel closure
due to coronary dissection, subacute recoil of the dilated coronary
lesion with the stenosis recurring relatively early, and later restenosis
due to the healing response invoked by vascular injury from the
procedure. Ultimately, supplementary technologies were needed to
resolve these issues and this led to the concept of deploying bare
metal stents (BMS) in the coronary artery. Early BMS were developed to
more reliably treat short, focal areas of disease. The aim of using these
devices was to cover disruption and stabilise dissection associated
with POBA, thus preventing abrupt vessel closure. In addition, the
vessel was scaffolded to prevent early recoil and the initial results
from widespread adoption of coronary intervention with BMS led to
benefits for patients.1 One feature of early BMS was that they were
relatively bulky and stiff devices. This reflected their initial function
for the treatment of focal and straightforward coronary lesions. As
the practice of interventional cardiology evolved to meet the needs of
patients with more complex coronary lesions, so too did the stents.
There was an explosion of different manufacturers, stent designs and
technologies.2 Therefore, early platforms quickly improved, becoming
easier to deliver and thus more user-friendly. Whilst the majority of
these devices were constructed from stainless steel, there was a
range of stent cell construction (open versus closed), cell geometry,
strut thickness and different materials were also explored (such as
gold, carbon and a variety of others).
However, it soon became clear that BMS were beset by the late
complication of in-stent restenosis (ISR). This late ‘healing phenomenon’
led to loss of the treated vessel lumen and a recurrence of ischaemia.
Repeat procedures (target lesion revascularisation [TLR] and target
vessel revascularisation [TVR]) became a frequent occurrence after
PCI with BMS. It also became apparent that ISR was associated with
many of the design features of these devices. These included longer
stent length, smaller stent diameter, a high metal:artery ratio and
strut thickness.3–5 Clinical features such as the presence of diabetes
also contributed to stent failure.3 There were both early and long-term
adverse consequences of ISR for patients.6,7 These events also led to a
clinical disadvantage for patients with multivessel disease who were
treated by PCI compared with those who were offered coronary artery
bypass grafting (CABG).8,9
Ultimately, this brought about the development of drug-eluting
stents (DES). These devices were first introduced in the pivotal
Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-
Expandable Stent in the Treatment of Patients with de Novo Native
Coronary Artery Lesions (RAVEL) trial.10 DES had polymers and a
variety of different drugs coated onto stents to stop late lumen loss.
The therapeutic goal was to reduce the inflammatory and healing
response that occurred after stent implantation, with the aim of

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preventing ISR and its clinical consequences. DES were very effective
in reducing levels of ISR relative to BMS and their use quickly became
widespread. However, their introduction and dissemination meant
that the original design concepts that applied BMS now also needed
to facilitate timed and consistent drug delivery. By this time, the
design goals that previously applied to stent manufacture had been
expanded and significantly altered. Investigations of different drugs,
polymers and their combinations became prominent and essentially
superseded platform design as manufacturers sought to produce
increasingly safe and effective devices.
One significant effect of DES was that patients with a previously
difficult disease, such as those with diabetes or multivessel disease,
could be treated.11,12 As a result, more and more challenging lesions
became amenable to PCI. In addition, stent design was also pushed
forwards by operator feedback that led manufacturers to encompass
potentially desirable properties in their products. These included
improved radiographic visibility, flexibility, device deliverability and
conformity to the vessel. In general, the overall trend in design goals
was to produce thinner stents that are more flexible but where the key
mechanical property of the stent (the radial strength and hence the
scaffold within the vessel) has been preserved.
Stent platform design and manufacture has now come back under the
clinical spotlight for a variety of reasons. These include the expanding
use of these devices in previously ‘taboo’ clinical areas (bifurcations,
chronic total occlusions, left main disease) with an increasingly
complex demand placed on their mechanical performance. It has
become apparent that these properties are paramount not only with
regard to the mechanical properties of the stents but also to clinical
outcomes in these challenging clinical scenarios.
Stent Materials, Design, Longitudinal Strength
and Stent Fracture
Metallic stents are manufactured by different processes. These
include laser cut slotted tubes, multilink hoops and the sinusoidal
continuous wire, which is a single unit that is wound, folded and
welded into shape. The stent must apply sufficient radial force on
the wall of the diseased coronary artery so that the vessel lumen is
restored to a near normal diameter whilst subsequently scaffolding
the vessel and preventing collapse of the artery in the longer term.
Desirable performance characteristics include low elastic recoil,
conformability, high visibility and ease of deliverability. The latter is a
complex parameter influenced by the flexibility afforded by the stent
itself, the properties of the delivery balloon system and the overall
crossing profile of the entire device.
Mechanical engineering is a science of compromise. Therefore,
altering any single feature of a stent inevitably affects other properties.
There is a complex interaction between every feature of stent design
and how the device behaves in clinical practice.13 The radio-opacity
of a stent is mainly dictated by the material (usually a metallic alloy)
from which it is constructed, where the resistance to penetration
by X-ray is proportional to the cube of the atomic number of the
elements that make up the alloy.13 There are a range of metallic alloys
that are employed in commonly used stents. These include stents that
are constructed from 316L stainless steel, cobalt chromium alloys
(MP35N and L605) and platinum chromium alloys (see Figure 1 and
Table 1 for examples). The alloy that the stent is constructed from
will not only alter the radio-opacity but also the elastic modulus (a
90
walsh_aiza_edited.indd 90
material’s tendency to be deformed elastically or non-permanently
when a force is applied to it), yield strength (the stress at which
a material exhibits plastic or permanent deformation) and tensile
strength (the maximum stress that a material can withstand whilst
stretched or pulled before its cross-sectional area significantly
contracts).14 In clinical terms, these latter features dictate the overall
radial strength of the stent itself, in addition to its susceptibility to
recoil. These two features are not mutually exclusive. However, these
properties are crucial for both the acute and long-term performance
of the stent. The evolution away from stainless steel towards other
alloys has been to allow the stent struts to become thinner whilst
maintaining the overall radial strength of the device.
Most recently, bioresorbable stents have been introduced to the clinical
arena. The most extensively studied stent is currently the Absorb™
(Abbott Vascular, Santa Clara, CA, US). This stent is manufactured
from a poly-L-lactic acid (PLLA) polymer. This semi-crystalline polymer
is constructed from a number of linked sinusoidal hoops with stent
struts that are 150  µm thick.15 This particular stent cannot be seen
radiographically and has two small metallic markers sited at the distal
and proximal stent edges for intra-procedural identification. A number
of other bioresorbable materials and platforms are under investigation
at various stages,15 although a review of these materials and devices is
beyond the scope of this article. Nevertheless, the same mechanical
constraints and desirable properties are also directly applicable to
these devices.
A major factor in stent design is the geometry of the stent cell
structure (see Table 1). This is dictated by the number and pattern
of connectors between rings or hoops. Reducing the number of fixed
connectors is potentially desirable as this improves flexibility, delivery
and decreases the metal:artery ratio. However, this also potentially
impacts negatively on longitudinal strength. It has recently become
apparent that longer, thinner and more flexible stents can be less
stable in their longitudinal axis. These stents can be ‘compressed’
or distorted along the length of the device creating a ‘concertina’
effect or longitudinal stent deformation (LSD).16,17 This phenomenon is
now well-understood and usually relates to an interaction between
guiding catheters and stents deployed in the aorto-ostial position, or
stents that are relatively undersized after initial deployment that are
subsequently ‘caught’ and distorted by secondary equipment that is
passed into the coronary vessel.14,16
With regard to longitudinal stability, there are several technical design
factors that are associated with an increased susceptibility to LSD. It
has been shown that at compressive forces of 50 gF (0.5 N) or less, it
is possible to shorten18 or elongate19 modern metallic stents. Stent alloy
and strut thickness appear to be somewhat less important with regard to
susceptibility to LSD. The construction of the device, number of connectors
between rings and their geometrical distribution across the device dictate
the longitudinal strength of the platform. In general, more connectors
between rings correlate with increasing longitudinal strength. Where
connectors are present, those that are in longitudinal alignment confer
increasing strength, whilst offset connectors are less strong. However,
there is a significant downside to increasing the longitudinal strength of
the device. This will increase the ‘stiffness’ of the stent, therefore reducing
its deliverability to and conformability within the vessel.
Whilst unrecognised, LSD has the potential to be clinically disastrous
for the patient. However, these events appear to be relatively rare.
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 Clinical Impact of Stent Design

Figure 1: Examples of Some Drug-eluting and Bare Metal Stents

The drug eluting stent is listed above, with the corresponding bare metal version annotated below. The material that the stents are manufactured from and strut thickness are noted. These
are drawn to scale. Strut thickness refers to the axis measured as if from the lumen to the vessel wall.

Table 1: Examples of Commonly Used Metallic Drug-eluting Stents

Manufacturer Drug-eluting Stents Material Drug Connectors/Ring Geometry

Abbott Vascular (CA, US) Xience Prime™ Cobalt chromium (L605) Everolimus 3

Biosensors (Singapore) Biomatrix™ Stainless steel (316L) Biolimus 2

Boston Scientific (MA, US) Promus Element™ Platinum chromium Everolimus 2

Medtronic (MN, US) Integrity Resolute™ Cobalt chromium (MP35N) Zotarolimus 2

The manufacturer, alloys, drugs eluted, number of connectors between rings and stent geometry are outlined.

Where LSD does occur, a three-pronged approach is required
to manage the stent deformation. Ideally, preventative measures
should be undertaken, such as prudent guide catheter selection in
ostial lesions to allow for sufficient support without excessive guide
engagement. Choosing a stent of an appropriate size and careful
proximal stent optimisation (usually with softer semi-compliant
balloons in our practice), particularly in the left main stem, will help
to ensure that secondary devices are unlikely to catch on struts
and cause deformation. Secondly, a low threshold is required for
suspecting stent deformation, particularly when there is resistance
in delivering post-dilation balloons. Careful fluoroscopy examination
and or additional imaging with intravascular ultrasound (IVUS)/optical
coherence tomography (OCT) may be necessary to diagnose this
problem.16 Finally, if longitudinal stent compression has occurred,
cautious post-dilation should be attempted. Small diameter balloons
may initially be required to cross the damaged stent, and these can
be gradually upsized as necessary. This method has been used with
success in our experience.16 Further proximal stent deployment may
be needed in the setting of vessel damage.14,16 It is worth noting that
this phenomenon can also occur with bioresorbable platforms (see
Figure 2). Should this occur, OCT will be necessary to demonstrate
the complication.
Nevertheless, there is a clear trade-off with increasing the stiffness
of a stent. Whilst longitudinal stability rises with the number of
stent connectors, the risk of stent fracture increases as the stent
becomes stiffer. Therefore, older stent platforms are much more
susceptible to this phenomenon. In one clinical study, the 6-connector
Cypher stent was more than four-times more likely to fracture than
newer platforms.20 The incidence of stent fracture with the Nobori™
2-connector Biolimus eluting stent (Terumo Corporation, Tokyo, Japan)
is reported at >4 % per lesion at nine-month angiographic assessment
in a study of >1,000 patients.21 This may relate to the exact shape
of the connector between rings for this particular stent. Fracture
has also been described in the thinner strut, 3-connector Xience™
stents (Abbott Vascular, Santa Clara, CA, US) where a combination
of LSD and stent fracture were also associated with adverse clinical
events.22 This was particularly likely to occur at areas of stent overlap.
Another study has suggested an incidence of stent fracture in Xience
stents at almost 3 % in a large cohort of >1,000 patients undergoing

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Figure 2: Optical Coherence Tomography Images of a provided that it is recognised. Our experience is that patients do well
Well-deployed Bioresorbable Vascular Scaffold (A) and the over the long term when this is the case. In contrast, stent fracture
Same Stent After Longitudinal Deformation Caused by a
is much more difficult to predict and it also seems to be a more
Guide Catheter (B)
common phenomenon than was previously considered to be the
case. Furthermore, there is a high chance of an adverse outcome with
stent fracture. Whilst LSD is certainly not desirable, the trade-off of a
more flexible and conformable stent platform with less axial stability
may be worthwhile if these platforms prevent later complications
that are likely to occur in significant numbers. This is becoming
increasingly relevant in the era of treating long segments of disease
with stents that can be as long as 48  mm and the frequent need
for overlapping stents (as is common when treating chronic total
occlusions). Newer approaches have been adopted more recently.
For example, the Promus Premier™ and Synergy™ II stent models
(Boston Scientific, Natick, MA, US) aim to retain flexibility through
the body of the stent by using two offset connectors. However, the
Table 2: Stent Models Within Different Manufacturer’s most proximal three rings are linked by extra connectors to provide
Platforms and Manufacturer Recommended resistance to LSD.
Over-expansion Limits
Stent Models Across a Product Range,
Manufacturer Platform Model’s Over-expansion Bifurcations and Over-expansion
Nominal Limit
Expansion
It is imperative that cardiologists are intimately familiar with the
Abbott Vascular Xience 2.25 mm 3.25 mm stents that they use. A differing range of stents occur within the
(CA, US) Xpedition™ 2.50 mm various manufacturer product ranges (see Table 2). Understanding
2.75 mm 4.00 mm the differences between the stents within these product ranges is key
3.00 mm to obtaining a good clinical outcome for the patient. This is becoming
3.25 mm more important as the lesion complexity increases. For example, using
3.50 mm 4.50 mm a two-stent strategy at a bifurcation could potentially have a vastly
4.00 mm
different mechanical result depending on which product is chosen. If
Biosensors Biomatrix 2.25 mm 3.50 mm
a 2.5 mm diameter product is brought from a side branch back into a
(Singapore) Flex™ 2.50 mm
much larger diameter main vessel, the final expansion in the proximal
3.00 mm
3.50 mm 4.50 mm
main vessel and stent cell diameter (and thus lumen achieved in
4.00 mm the main vessel) will be very different than if a 3  mm or 4  mm
Boston Scientific Promus 2.25 mm 2.75 mm version of the ‘same stent’ is deployed in the side branch instead.
(MA, US) Premier™ 2.50 mm 3.50 mm Understanding the implications of these choices is crucial. This is
2.75 mm particularly pertinent when the left main stem (LMS) is being treated.
3.00 mm 4.25 mm
3.50 mm With LMS intervention, over-expansion of current stent platforms is
4.00 mm 5.75 mm frequently required as the devices are brought back from smaller
Synergy™ 2.25 mm 3.50 mm
diameter daughter vessels (LAD or left circumflex). Despite bench
2.50 mm
testing demonstrating that current drug-eluting stent platforms can
2.75 mm
maintain structural integrity beyond the nominal expansion diameter,24
3.00 mm 4.25 mm
3.50 mm
there are theoretical concerns that over-expansion may affect drug
4.00 mm 5.75 mm delivery and cause mechanical disruption of the stent.
Medtronic Resolute 2.25 mm 3.50 mm
(MN, US) Integrity™ 2.50 mm The first concern regarding over-expansion is that it may damage the
2.75 mm stent polymer, leading to uneven drug elution, with a potential for later
3.00 mm 4.75 mm ISR.25 Bench testing of over-expansion of first generation DES found
3.50 mm that balloon dilation induced only minor polymer coating abnormalities,
4.00 mm which have also been noted on undeployed DES.26,27 It is also possible to
replicate this polymer damage by delivering stents through tortuous and
follow-up angiography between 6 and 9 months.23 Stent fracture is calcified vessels. Another concern with respect to over-expansion is the
likely to lead to ISR, acute or chronic occlusion and is certainly not risk of mechanical disruption of the stent. Stent fracture is possible with
a benign phenomenon.20–23 These events are predisposed by certain overly aggressive stent expansion.
features within the lesion or vessel. These include treating the right
coronary artery, using longer stents, areas of tortuosity, calcification, A further mechanical issue with over-expansion that has been queried
stent malapposition and stenting at hinge points. is of the potential for stent recoil. This is a theoretical concern due to
a reduction in metal:artery ratio and an alteration of the scaffold itself.
Therefore, whilst LSD can occur as a sudden and dramatic event Stent recoil has been described when treating atheromatous vessels.28
that complicates a PCI, this can usually be managed and resolved However, in the LMS the usual reason for over-expansion is apposition

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to the non-diseased vessel wall rather than scaffolding flow limiting
plaque. Furthermore, the radial strength of the stent paradoxically
increases as it is over-expanded. This is due to straightening of both
the ring and connectors, thus leading to greater strength, not less.
Our experience of LMS PCI is that this is typically a very large vessel.
In a study of 125 patients, the mean cross-sectional area of the distal
LMS was 22.6  mm2 (standard deviation [SD] ± 5.4  mm2) and mean
maximal vessel diameter was 5.7  mm (SD ± 0.7  mm).29 Therefore,
the vast majority of patients would consequently require post-dilation
beyond the nominal diameter of all of the large vessel platforms
of current generation DES during LMS PCI. We also performed a
further prospective clinical study where all patients who underwent
IVUS-guided LMS PCI and stent post-dilation beyond suggested expansion
limits were entered into a registry. In 31 patients, mean maximal stent
diameters of >5.0  mm were reliably achieved (using Biomatrix Flex™
9 crown and Promus Element Large vessel platforms) with 5.5  mm
and 6.0  mm post-dilation balloons. No intra-procedural complications
occurred and in 13.4 months of follow-up only one patient experienced
clinical ISR.29 This indicates excellent short-term efficacy and no increased
complication rate with over-expansion of current generation DES in the
LMS. These results compliment the bench data of Foin et al., but in the
clinical arena.24 It should be noted that under-expansion or incomplete
stent apposition of BMS or DES is strongly associated with ISR and stent
thrombosis.30–32 We would suggest that leaving undersized and unapposed
or malapposed stents in the LMS should be avoided at all costs.
Conclusions and Future Directions
The evolution of the role of stents has resulted in a significant change
in stent design, primarily driven by the requirements of the disease
that is being treated. Stent design is crucial for acute and long-term
outcomes for patients and it is critical that cardiologists have a
complete understanding of the design features of the devices that
they are implanting.
It is likely that LMS PCI and the treatment of large vessel bifurcations
will become a mainstream application of PCI over the forthcoming
years. Manufacturers may need to consider producing dedicated
platforms for the treatment of these vessels. As more patients with
multivessel disease are treated greater attention will also need to be
placed on longer-term outcomes in more demanding clinical settings.
The risks of latent stent fracture may assume a more prominent role
in clinical studies in future. Ultimately, as the clinical practice of PCI
continues to evolve, manufacturers and clinicians will have to work
closely in partnership to make sure that the devices that are implanted
can provide excellent safety and long-term efficacy for patients. The
importance of stent design has been re-emphasised and is likely to
become increasingly relevant in future, where the patient and lesion
being treated are likely to mandate very careful selection of the stents
that are deployed in each individual setting. The focus should be
shifted away from producing ever more deliverable stent platforms
and should be moved back to the fundamental properties of what the
device has been built to achieve. n

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